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Updated: Nov 18, 2025

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
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Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of

Edward S Kim1, Thomas S Uldrick2, Caroline Schenkel3

  • 1City of Hope Orange County and National Medical Center, Los Angeles, California. edwkim@coh.org.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
|February 10, 2021
PubMed
Abstract

Insights

New recommendations aim to broaden clinical trial eligibility criteria (EC), making research more inclusive and representative. This will increase patient access to investigational treatments and improve generalizability of findings.

Area of Science:

  • Oncology
  • Clinical Trials
  • Medical Research

Background:

  • Restrictive eligibility criteria (EC) in clinical trials limit patient enrollment and the generalizability of results.
  • Previous recommendations in 2017 prompted further analysis and working groups by the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends).

Discussion:

  • Multistakeholder working groups proposed updated recommendations for inclusive EC concerning washout periods, concomitant medications, prior therapies, laboratory values, and performance status.
  • These modernized EC aim to enhance the representativeness of cancer patient populations in clinical trials.

Key Insights:

  • The ASCO Board of Directors and Friends leadership endorse the proposed recommendations for more inclusive EC.
  • Implementation is expected to simplify eligibility determination and increase patient participation in research.

Outlook:

  • Broader participation addresses underrepresentation of specific groups in clinical trials.
  • More inclusive trials will generate evidence applicable to a wider patient population and potentially accelerate trial accrual.

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